Reduces thrombotic cardiovascular events (including stent thrombosis). ANDA 205987, held by Accord Hlthcare. Prasugrel Hydrochloride.
As of Nov 15, 2026, ANDA 205987 (Prasugrel), held by Accord Hlthcare, was first approved by FDA on Feb 2, 2018, with 4 approved supplements and 0 published complete response letters.
Prasugrel is a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina or, non-ST-elevation myocardial infarction (NSTEMI). Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 2, 2018 | Original application | Approved | None posted |
| PrasugrelEQ 5MG BASE · tablet;oral | Prasugrel Hydrochloride | Rx |
| PrasugrelEQ 10MG BASE · tablet;oral | Prasugrel Hydrochloride | Rx |
| May 29, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| Apr 12, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 4, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 4, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 2, 2018 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
